Government-Owned Inventions; Availability for Licensing, 46309-46311 [2015-19082]

Download as PDF tkelley on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Notices Place: National Institutes of Health, Building 31, 31 Center Drive, Conference Room 10, Bethesda, MD 20892. Contact Person: Brent B. Stanfield, Ph.D., Director, Division of Extramural Activities, National Institutes of Diabetes And Digestive and Kidney Diseases, 6707 Democracy Blvd. Room 715, MSC 5452, Bethesda, MD 20892, (301) 594–8843, stanfibr@niddk.nih.gov. Name of Committee: National Diabetes and Digestive and Kidney Diseases Advisory Council; Kidney, Urologic and Hematologic Diseases Subcommittee. Date: September 9, 2015. Open: 1:00 p.m. to 3:00 p.m. Agenda: To review the Division’s scientific and planning activities. Place: National Institutes of Health, Building 31, 31 Center Drive, Conference Room 7, Bethesda, MD 20892. Closed: 3:00 p.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Building 31, 31 Center Drive, Conference Room 7, Bethesda, MD 20892. Contact Person: Brent B. Stanfield, Ph.D., Director, Division of Extramural Activities, National Institutes of Diabetes And Digestive and Kidney Diseases, 6707 Democracy Blvd. Room 715, MSC 5452, Bethesda, MD 20892, (301) 594–8843, stanfibr@niddk.nih.gov. Name of Committee: National Diabetes and Digestive and Kidney Diseases Advisory Council; Digestive Diseases and Nutrition Subcommittee. Date: September 9, 2015. Open: 1:00 p.m. to 3:00 p.m. Agenda: To review the Division’s scientific and planning activities. Place: National Institutes of Health, Building 31, 31 Center Drive, Conference Room 6, Bethesda, MD 20892. Closed: 3:00 p.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Building 31, 31 Center Drive, Conference Room 6, Bethesda, MD 20892. Contact Person: Brent B. Stanfield, Ph.D., Director, Division Of Extramural Activities, National Institutes of Diabetes And Digestive and Kidney Diseases, 6707 Democracy Blvd. Room 715, MSC 5452, Bethesda, MD 20892 (301) 594–8843, stanfibr@niddk.nih.gov. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. Information is also available on the Institute’s/Center’s home page: www.niddk.nih.gov/fund/divisions/DEA/ Council/coundesc.htm., where an agenda and VerDate Sep<11>2014 18:45 Aug 03, 2015 Jkt 235001 any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: July 29, 2015. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–19024 Filed 8–3–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. FOR FURTHER INFORMATION CONTACT: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852–3804; telephone: 301– 496–7057; fax: 301–402–0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. SUPPLEMENTARY INFORMATION: Technology descriptions follow. Interferon Alpha Hybrids Description of Technology: Available for licensing are hybrid interferon alpha (INF-alpha) polypeptides constructed by combinations of INFalpha21b and INFalpha2c, and mutants of these hybrids. These hybrid constructs have resulted in novel IFNs that either combine different biological properties from the parent proteins or have significantly different biological activity from both the parents in antiproliferative, anti-viral, or competitive Frm 00076 Fmt 4703 binding properties. For instance, the hybrid designated HY–3 has higher antiproliferative activity in Daudi, WISH, and primary human lymphocyte cells exhibiting approximately 6 times higher anti-proliferative activity than either parent IFN. These IFN hybrids provide a powerful tool for studying the structure-function relationship of these molecules. The engineered IFN-alpha proteins may have important new therapeutic applications and may provide greater insights into understanding of the clinical activities of existing IFN-alphas. Also available for licensing are hybrid INF-alpha nucleic acids encoding the hybrid polypeptides as well as cells, vectors, pharmaceutical compositions with these nucleic acid sequences. Potential Commercial Applications • Anti-viral and cancer therapeutics • Research tool to study IFN-alpha functions Competitive Advantages Notice. SUMMARY: PO 00000 46309 Sfmt 4703 • Ease of manufacture • Strong anti-viral activity Development Stage: In vitro data available. Inventors: Kathryn C. Zoon (NIAID), Joseph B. Bekisz (NIAID), Mark P. Hayes (FDA), Renqiu Hu (FDA). Publications 1. Hu R, et al. Protein engineering of interferon alphas. Methods Mol Med. 2005;116:69–80. [PMID 16000855] 2. Hu R, et al. Human IFN-alpha protein engineering: the amino acid residues at positions 86 and 90 are important for antiproliferative activity. J Immunol. 2001 Aug 1;167(3):1482–9. [PMID 11466368] 3. Hu R, et al. Divergence of binding, signaling, and biological responses to recombinant human hybrid IFN. J Immunol. 1999 Jul 15;163(2):854–60. [PMID 10395679] Intellectual Property: HHS Reference No. E–068–1998/0— • US Patent No. 6,685,933 issued 03 Feb 2004 • US Patent No. 7,235,232 issued 26 Jun 2007 Licensing Contact: Peter Soukas; 301– 435–4646; ps193c@nih.gov. Novel Treatment for Anemia and Polycythemia: AVPR1B Molecules Modulating Erythropoiesis Description of Technology: Anemia can be caused by chronic diseases, chemotherapy, or radiation. Erythropoietin is commonly used to stimulate red blood cell production for anemia treatment, but it takes about a week to manifest its clinical effect. The E:\FR\FM\04AUN1.SGM 04AUN1 46310 Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Notices subject invention describes the arginine vasopressin receptor 1B (AVPR1B) stimulatory molecules that can be used to stimulate hematopoietic stem cell proliferation. Preliminary results from animal studies suggest that the number of red blood cells and their precursors significantly increased on day 2 following AVP administration, an onset time much faster than erythropoietin. The AVPR1B stimulatory molecules can be used to jumpstart the system and erythropoietin can be used to sustain the effect. In addition, the AVPR1B inhibitory molecules can be used to suppress hematopoietic stem cell proliferation to treat polycythemia (overproduction of red blood cells). Potential Commercial Applications • Treatment of anemia caused by chronic diseases, chemotherapy, or radiation. • Anemia patients who do not respond to erythropoietin. • Polycythemia treatment. Competitive Advantages: AVPR1B stimulatory molecules act faster than the commonly used erythropoietin for anemia treatment. are among the most frequently used viral vectors for gene therapy because AAV vectors can infect both dividing and non-dividing cells, and can establish long-term transgene expression. Two major issues in gene therapy are the ability to efficiently transduce the target cells and to evade the immune response to vectors. The subject invention describes a mutated AAV serotype 5 by modifying sialic acid binding regions which mediate viral entry into host cells. Preliminary results from animal studies suggest that this modification can increase transduction by 3–4 folds in salivary glands and muscle, and can significantly decrease the potential of being neutralized by preexisting antibodies compared to the wild type. Thus, the modified AAV5 vectors seem to be optimal for gene therapy. Potential Commercial Applications: Genetically engineered AAV5 vectors for gene therapy. Competitive Advantages • Enhanced transduction activity. • Reduced the potential for being neutralized by preexisting antibodies. Development Stage • Early-stage • In vivo data available (animal) Inventors: Eva Mezey and Miklos Krepuska (NIDCR); Balazs Mayer and Krisztian Nemeth (Semmelweis University Medical School) Intellectual Property: HHS Reference No. E–619–2013/0— • US Application No. 61/885,258 filed October 01, 2013 (E–619–2013/0–US– 01) • PCT Application No. PCT/US2014/ 058613 filed October 01, 2014 (E– 619–2013/0–PCT–02) Licensing Contact: Sally Hu, Ph.D., M.B.A.; 301–435–5605; hus@ mail.nih.gov. Collaborative Research Opportunity: The National Institute of Dental and Craniofacial Research is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize treatment for anemia and polycythemia. For collaboration opportunities, please contact David Bradley, Ph.D. at bradleyda@ nidcr.nih.gov. tkelley on DSK3SPTVN1PROD with NOTICES Development Stage • Early-stage • In vivo data available (animal) Inventors: John Chiorini and Sandra Afione-Wainer (NIDCR); Mavis Agbandje-Mckenna and Sujata Halder (University of Florida). Modified AAV5 Vectors for Enhanced Transduction and Reduced Antibody Neutralization Description of Technology: Adenoassociated viruses (AAVs) are small nonpathogenic viruses and can integrate into the cellular genome. AAV vectors VerDate Sep<11>2014 18:45 Aug 03, 2015 Jkt 235001 Publications 1. Afione S, et al. Identification and mutagenesis of the adeno-associated virus 5 sialic acid binding region. J Virol. 2015 Feb; 89(3): 1660–72. [PMID 25410855] 2. Chiorini J, et al. AAV4 Vector and the uses thereof. U.S. Patent 6,468,524, issued on October 22, 2002. 3. Chiorini J, et al. AAV5 Vector and the uses thereof. U.S. Patent 7,479,554, issued January 20, 2009, and U.S. Patent 6.984,517, issued on January 10, 2006. 4. Chiorini J, et al. AAV5 Vector for transducing brain cells and lung cells. U.S. Patent 6,855,314, issued on February 15, 2005. Intellectual Property: HHS Reference No. E–097–2015/0—US Application No. 62/143,524 filed April 6, 2015. Related Technologies • E–175–2015: US 62/160,552. • E–736–2013: PCT/US14/59825. • E–142–2011 family: PCT/US12/ 34268, CA, EP and US. • E–087–2011 family: PCT/US12/ 33556, EP and US. • E–232–2011: US 14/428,929. • E–194–2010: US 8,808,684. • E–179–2005: US 8,283,151. PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 • E–227–2004: US 7,407,801. • E–329–2003 family: US 8,137,960, US 8,685,722. • E–105–2003: US 8,927,269. • E–308–2001: US 7,419,817. • E–071–2000: US 6,468,524. • E–127–1998 family: US 6,984,517, AU, CA, EP, and JP. Licensing Contact: Sally Hu, Ph.D., M.B.A.; 301–435–5606; hus@ mail.nih.gov. Collaborative Research Opportunity: The National Institute of Dental and Craniofacial Research is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize modified AAV5 vector for gene therapy. For collaboration opportunities, please contact David Bradley, Ph.D. at bradleyda@ nidcr.nih.gov. A Novel Adeno-Associated Virus for Gene Therapy Description of Technology: Adenoassociated viruses (AAVs) are small nonpathogenic viruses and can integrate into the cellular genome. AAV vectors are among the most frequently used viral vectors for gene therapy because AAV vectors can infect both dividing and non-dividing cells, and can establish long-term transgene expression. The subject invention describes a novel AAV termed ‘‘44–9.’’ AAV44–9 based vectors have high gene transfer activity in a number of cell types, including salivary gland cells, liver cells, and different types of neurons (e.g., cells of the cortex, olfactory bulb, and brain stem, and Purkinje cells of the cerebellum). These vectors can deliver heterologous genes to particular target cells through sitespecific administration. Preliminary results from animal studies suggest that AAV44–9 vectors can efficiently deliver genes of interest, and the protein products of the delivered genes can be detected in bloodstream and at the local tissues. Therefore, these vectors are suitable for gene therapy for cells/ tissues that are not efficiently targeted by other vectors. Potential Commercial Applications: AAV44–9 can be used as a delivery vector in gene therapy. Competitive Advantages • High gene transfer activity in a number of cell types including salivary gland cells, liver cells, and different types of neurons (e.g., cells of the cortex, olfactory bulb, and brain stem, and Purkinje cells of the cerebellum). • As a gene transfer vector for cells that are not efficiently targeted by other vector. E:\FR\FM\04AUN1.SGM 04AUN1 Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Notices Development Stage • In vitro data available • In vivo data available (animal) Inventors: John Chiorini and Giovanni Pasquale (NIDCR). Publication: Schmidt M, et al. Identification and characterization of novel adeno-associated virus isolates in ATCC virus stocks. J Virol. 2006 May; 80 (10): 5082–5098. [PMID 16641301] Intellectual Property: HHS Reference No. E–175–2015/0—US Application No. 62/160,552 filed May 12, 2015. tkelley on DSK3SPTVN1PROD with NOTICES Related Technologies • E–097–2015: US 62/143,524. • E–736–2013: PCT/US14/59825. • E–142–2011 family: PCT/US12/ 34268, CA, EP and US. • E–087–2011 family: PCT/US12/ 33556, EP and US. • E–232–2011: US 14/428,929. • E–194–2010: US 8,808,684. • E–179–2005: US 8,283,151. • E–227–2004: US 7,407,801. • E–329–2003 family: US 8,137,960, US 8,685,722. • E–105–2003: US 8,927,269. • E–308–2001: US 7,419,817. • E–071–2000: US 6,468,524. • E–127–1998 family: US 6,984,517, AU, CA, EP, and JP. Licensing Contact: Sally Hu, Ph.D., M.B.A.; 301–435–5606; hus@ mail.nih.gov. Collaborative Research Opportunity: The National Institute of Dental and Craniofacial Research is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize AAV44–9 vector for gene therapy. For collaboration opportunities, please contact David Bradley, Ph.D. at bradleyda@ nidcr.nih.gov. WNT1-Induced Secreted Protein-1 Knockout Mouse Model Description of Technology: WNT1induced secreted protein-1 (WISP1) is expressed at high levels in osteoblasts and their precursors. WIPS1 plays an important role in various aspects of bone formation. Scientists at the NIH generated Wisp1-deficient (Wisp1-/-) mice. Deletion of Wisp1 resulted in a decrease in bone mineral density, total bone volume, bone thickness, and biomechanical strength. Wisp1 knockout mouse model can be used to study the molecular mechanisms of bone turnover and patho/physiology of tissues that express WISP1. Potential Commercial Applications • To study the molecular mechanisms of bone formation and osteodifferentiation. VerDate Sep<11>2014 18:45 Aug 03, 2015 Jkt 235001 • To study the patho/physiology of tissues that express WISP1, including cartilage during osteoarthritis, healing skin, and other soft tissues including lung, pancreas, and heart. Development Stage: In vivo data available (animal). Inventors: Marian F. Young, Mitsuaki Ono, Azusa Maeda (all of NIDCR). Publication: Maeda A, et al. WNT1induced secreted protein-1 (WISP1), a novel regulator of bone turnover and Wnt signaling. J Bio Chem. 2015 May 29;290(22):14004–18. [PMID 25864198] Intellectual Property: HHS Reference No. E–234–2015/0—Research Tool. Patent protection is not being pursued for this technology. Licensing Contact: Sally Hu, Ph.D., M.B.A.; 301–435–5606; hus@ mail.nih.gov Collaborative Research Opportunity: The National Institute of Dental and Craniofacial Research is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize WNT1-Induced Secreted Protein-1 Knockout Mouse Model. For collaboration opportunities, please contact David Bradley, Ph.D. at bradleyda@nidcr.nih.gov. Dated: July 30, 2015. Richard U. Rodriguez, Acting Director, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2015–19082 Filed 8–3–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES 46311 Emphasis Panel; Review of U24 Applications for Parkinson’s Disease Repositories. Date: August 11, 2015. Time: 9:00 a.m. to 1:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Joel A. Saydoff, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research, NINDS/NIH/DHHS/Neuroscience Center, 6001 Executive Boulevard, Suite 3205, MSC 9529, Bethesda, MD 20892–9529, 301–435– 9223, joel.saydoff@nih.gov. Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel; Review of U01 Applications for Parkinson’s Disease Biomarker Program. Date: August 12, 2015. Time: 8:00 a.m. to 12:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Joel A. Saydoff, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research, NINDS/NIH/DHHS/Neuroscience Center, 6001 Executive Boulevard, Suite 3205, MSC 9529, Bethesda, MD 20892–9529, 301–435– 9223. (Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research Related to Neurological Disorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS) Dated: July 29, 2015. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–19032 Filed 8–3–15; 8:45 am] National Institutes of Health BILLING CODE 4140–01–P National Institute of Neurological Disorders and Stroke: Notice of Closed Meetings DEPARTMENT OF HEALTH AND HUMAN SERVICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Neurological Disorders and Stroke Special PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 National Institutes of Health Center for Scientific Review: Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which E:\FR\FM\04AUN1.SGM 04AUN1

Agencies

[Federal Register Volume 80, Number 149 (Tuesday, August 4, 2015)]
[Notices]
[Pages 46309-46311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19082]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The inventions listed below are owned by an agency of the U.S. 
Government and are available for licensing in the U.S. in accordance 
with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious 
commercialization of results of federally-funded research and 
development. Foreign patent applications are filed on selected 
inventions to extend market coverage for companies and may also be 
available for licensing.

FOR FURTHER INFORMATION CONTACT: Licensing information and copies of 
the U.S. patent applications listed below may be obtained by writing to 
the indicated licensing contact at the Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, Maryland 20852-3804; telephone: 301-496-7057; fax: 301-402-
0220. A signed Confidential Disclosure Agreement will be required to 
receive copies of the patent applications.

SUPPLEMENTARY INFORMATION: Technology descriptions follow.

Interferon Alpha Hybrids

    Description of Technology: Available for licensing are hybrid 
interferon alpha (INF-alpha) polypeptides constructed by combinations 
of INFalpha21b and INFalpha2c, and mutants of these hybrids. These 
hybrid constructs have resulted in novel IFNs that either combine 
different biological properties from the parent proteins or have 
significantly different biological activity from both the parents in 
anti-proliferative, anti-viral, or competitive binding properties. For 
instance, the hybrid designated HY-3 has higher anti-proliferative 
activity in Daudi, WISH, and primary human lymphocyte cells exhibiting 
approximately 6 times higher anti-proliferative activity than either 
parent IFN. These IFN hybrids provide a powerful tool for studying the 
structure-function relationship of these molecules. The engineered IFN-
alpha proteins may have important new therapeutic applications and may 
provide greater insights into understanding of the clinical activities 
of existing IFN-alphas.
    Also available for licensing are hybrid INF-alpha nucleic acids 
encoding the hybrid polypeptides as well as cells, vectors, 
pharmaceutical compositions with these nucleic acid sequences.

Potential Commercial Applications

 Anti-viral and cancer therapeutics
 Research tool to study IFN-alpha functions

Competitive Advantages

 Ease of manufacture
 Strong anti-viral activity

    Development Stage: In vitro data available.
    Inventors: Kathryn C. Zoon (NIAID), Joseph B. Bekisz (NIAID), Mark 
P. Hayes (FDA), Renqiu Hu (FDA).

Publications

1. Hu R, et al. Protein engineering of interferon alphas. Methods 
Mol Med. 2005;116:69-80. [PMID 16000855]
2. Hu R, et al. Human IFN-alpha protein engineering: the amino acid 
residues at positions 86 and 90 are important for antiproliferative 
activity. J Immunol. 2001 Aug 1;167(3):1482-9. [PMID 11466368]
3. Hu R, et al. Divergence of binding, signaling, and biological 
responses to recombinant human hybrid IFN. J Immunol. 1999 Jul 
15;163(2):854-60. [PMID 10395679]

    Intellectual Property: HHS Reference No. E-068-1998/0--

 US Patent No. 6,685,933 issued 03 Feb 2004
 US Patent No. 7,235,232 issued 26 Jun 2007

    Licensing Contact: Peter Soukas; 301-435-4646; ps193c@nih.gov.

Novel Treatment for Anemia and Polycythemia: AVPR1B Molecules 
Modulating Erythropoiesis

    Description of Technology: Anemia can be caused by chronic 
diseases, chemotherapy, or radiation. Erythropoietin is commonly used 
to stimulate red blood cell production for anemia treatment, but it 
takes about a week to manifest its clinical effect. The

[[Page 46310]]

subject invention describes the arginine vasopressin receptor 1B 
(AVPR1B) stimulatory molecules that can be used to stimulate 
hematopoietic stem cell proliferation. Preliminary results from animal 
studies suggest that the number of red blood cells and their precursors 
significantly increased on day 2 following AVP administration, an onset 
time much faster than erythropoietin. The AVPR1B stimulatory molecules 
can be used to jumpstart the system and erythropoietin can be used to 
sustain the effect. In addition, the AVPR1B inhibitory molecules can be 
used to suppress hematopoietic stem cell proliferation to treat 
polycythemia (overproduction of red blood cells).

Potential Commercial Applications

     Treatment of anemia caused by chronic diseases, 
chemotherapy, or radiation.
     Anemia patients who do not respond to erythropoietin.
     Polycythemia treatment.
    Competitive Advantages: AVPR1B stimulatory molecules act faster 
than the commonly used erythropoietin for anemia treatment.

Development Stage

 Early-stage
 In vivo data available (animal)

    Inventors: Eva Mezey and Miklos Krepuska (NIDCR); Balazs Mayer and 
Krisztian Nemeth (Semmelweis University Medical School)
    Intellectual Property: HHS Reference No. E-619-2013/0--

 US Application No. 61/885,258 filed October 01, 2013 (E-619-
2013/0-US-01)
 PCT Application No. PCT/US2014/058613 filed October 01, 2014 
(E-619-2013/0-PCT-02)

    Licensing Contact: Sally Hu, Ph.D., M.B.A.; 301-435-5605; 
hus@mail.nih.gov.
    Collaborative Research Opportunity: The National Institute of 
Dental and Craniofacial Research is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate or commercialize treatment for anemia and 
polycythemia. For collaboration opportunities, please contact David 
Bradley, Ph.D. at bradleyda@nidcr.nih.gov.

Modified AAV5 Vectors for Enhanced Transduction and Reduced Antibody 
Neutralization

    Description of Technology: Adeno-associated viruses (AAVs) are 
small nonpathogenic viruses and can integrate into the cellular genome. 
AAV vectors are among the most frequently used viral vectors for gene 
therapy because AAV vectors can infect both dividing and non-dividing 
cells, and can establish long-term transgene expression. Two major 
issues in gene therapy are the ability to efficiently transduce the 
target cells and to evade the immune response to vectors. The subject 
invention describes a mutated AAV serotype 5 by modifying sialic acid 
binding regions which mediate viral entry into host cells. Preliminary 
results from animal studies suggest that this modification can increase 
transduction by 3-4 folds in salivary glands and muscle, and can 
significantly decrease the potential of being neutralized by 
preexisting antibodies compared to the wild type. Thus, the modified 
AAV5 vectors seem to be optimal for gene therapy.
    Potential Commercial Applications: Genetically engineered AAV5 
vectors for gene therapy.

Competitive Advantages

     Enhanced transduction activity.
     Reduced the potential for being neutralized by preexisting 
antibodies.

Development Stage

 Early-stage
 In vivo data available (animal)

    Inventors: John Chiorini and Sandra Afione-Wainer (NIDCR); Mavis 
Agbandje-Mckenna and Sujata Halder (University of Florida).

Publications

1. Afione S, et al. Identification and mutagenesis of the adeno-
associated virus 5 sialic acid binding region. J Virol. 2015 Feb; 
89(3): 1660-72. [PMID 25410855]
2. Chiorini J, et al. AAV4 Vector and the uses thereof. U.S. Patent 
6,468,524, issued on October 22, 2002.
3. Chiorini J, et al. AAV5 Vector and the uses thereof. U.S. Patent 
7,479,554, issued January 20, 2009, and U.S. Patent 6.984,517, 
issued on January 10, 2006.
4. Chiorini J, et al. AAV5 Vector for transducing brain cells and 
lung cells. U.S. Patent 6,855,314, issued on February 15, 2005.

    Intellectual Property: HHS Reference No. E-097-2015/0--US 
Application No. 62/143,524 filed April 6, 2015.

Related Technologies

     E-175-2015: US 62/160,552.
     E-736-2013: PCT/US14/59825.
     E-142-2011 family: PCT/US12/34268, CA, EP and US.
     E-087-2011 family: PCT/US12/33556, EP and US.
     E-232-2011: US 14/428,929.
     E-194-2010: US 8,808,684.
     E-179-2005: US 8,283,151.
     E-227-2004: US 7,407,801.
     E-329-2003 family: US 8,137,960, US 8,685,722.
     E-105-2003: US 8,927,269.
     E-308-2001: US 7,419,817.
     E-071-2000: US 6,468,524.
     E-127-1998 family: US 6,984,517, AU, CA, EP, and JP.
    Licensing Contact: Sally Hu, Ph.D., M.B.A.; 301-435-5606; 
hus@mail.nih.gov.
    Collaborative Research Opportunity: The National Institute of 
Dental and Craniofacial Research is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate or commercialize modified AAV5 vector for gene 
therapy. For collaboration opportunities, please contact David Bradley, 
Ph.D. at bradleyda@nidcr.nih.gov.

A Novel Adeno-Associated Virus for Gene Therapy

    Description of Technology: Adeno-associated viruses (AAVs) are 
small nonpathogenic viruses and can integrate into the cellular genome. 
AAV vectors are among the most frequently used viral vectors for gene 
therapy because AAV vectors can infect both dividing and non-dividing 
cells, and can establish long-term transgene expression. The subject 
invention describes a novel AAV termed ``44-9.'' AAV44-9 based vectors 
have high gene transfer activity in a number of cell types, including 
salivary gland cells, liver cells, and different types of neurons 
(e.g., cells of the cortex, olfactory bulb, and brain stem, and 
Purkinje cells of the cerebellum). These vectors can deliver 
heterologous genes to particular target cells through site-specific 
administration. Preliminary results from animal studies suggest that 
AAV44-9 vectors can efficiently deliver genes of interest, and the 
protein products of the delivered genes can be detected in bloodstream 
and at the local tissues. Therefore, these vectors are suitable for 
gene therapy for cells/tissues that are not efficiently targeted by 
other vectors.
    Potential Commercial Applications: AAV44-9 can be used as a 
delivery vector in gene therapy.

Competitive Advantages

     High gene transfer activity in a number of cell types 
including salivary gland cells, liver cells, and different types of 
neurons (e.g., cells of the cortex, olfactory bulb, and brain stem, and 
Purkinje cells of the cerebellum).
     As a gene transfer vector for cells that are not 
efficiently targeted by other vector.

[[Page 46311]]

Development Stage

 In vitro data available
 In vivo data available (animal)

    Inventors: John Chiorini and Giovanni Pasquale (NIDCR).
    Publication: Schmidt M, et al. Identification and characterization 
of novel adeno-associated virus isolates in ATCC virus stocks. J Virol. 
2006 May; 80 (10): 5082-5098. [PMID 16641301]
    Intellectual Property: HHS Reference No. E-175-2015/0--US 
Application No. 62/160,552 filed May 12, 2015.

Related Technologies

     E-097-2015: US 62/143,524.
     E-736-2013: PCT/US14/59825.
     E-142-2011 family: PCT/US12/34268, CA, EP and US.
     E-087-2011 family: PCT/US12/33556, EP and US.
     E-232-2011: US 14/428,929.
     E-194-2010: US 8,808,684.
     E-179-2005: US 8,283,151.
     E-227-2004: US 7,407,801.
     E-329-2003 family: US 8,137,960, US 8,685,722.
     E-105-2003: US 8,927,269.
     E-308-2001: US 7,419,817.
     E-071-2000: US 6,468,524.
     E-127-1998 family: US 6,984,517, AU, CA, EP, and JP.
    Licensing Contact: Sally Hu, Ph.D., M.B.A.; 301-435-5606; 
hus@mail.nih.gov.
    Collaborative Research Opportunity: The National Institute of 
Dental and Craniofacial Research is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate or commercialize AAV44-9 vector for gene therapy. For 
collaboration opportunities, please contact David Bradley, Ph.D. at 
bradleyda@nidcr.nih.gov.

WNT1-Induced Secreted Protein-1 Knockout Mouse Model

    Description of Technology: WNT1-induced secreted protein-1 (WISP1) 
is expressed at high levels in osteoblasts and their precursors. WIPS1 
plays an important role in various aspects of bone formation. 
Scientists at the NIH generated Wisp1-deficient (Wisp1-/-) mice. 
Deletion of Wisp1 resulted in a decrease in bone mineral density, total 
bone volume, bone thickness, and biomechanical strength. Wisp1 knockout 
mouse model can be used to study the molecular mechanisms of bone 
turnover and patho/physiology of tissues that express WISP1.

Potential Commercial Applications

     To study the molecular mechanisms of bone formation and 
osteodifferentiation.
     To study the patho/physiology of tissues that express 
WISP1, including cartilage during osteoarthritis, healing skin, and 
other soft tissues including lung, pancreas, and heart.
    Development Stage: In vivo data available (animal).
    Inventors: Marian F. Young, Mitsuaki Ono, Azusa Maeda (all of 
NIDCR).
    Publication: Maeda A, et al. WNT1-induced secreted protein-1 
(WISP1), a novel regulator of bone turnover and Wnt signaling. J Bio 
Chem. 2015 May 29;290(22):14004-18. [PMID 25864198]
    Intellectual Property: HHS Reference No. E-234-2015/0--Research 
Tool. Patent protection is not being pursued for this technology.
    Licensing Contact: Sally Hu, Ph.D., M.B.A.; 301-435-5606; 
hus@mail.nih.gov
    Collaborative Research Opportunity: The National Institute of 
Dental and Craniofacial Research is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate or commercialize WNT1-Induced Secreted Protein-1 
Knockout Mouse Model. For collaboration opportunities, please contact 
David Bradley, Ph.D. at bradleyda@nidcr.nih.gov.

    Dated: July 30, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2015-19082 Filed 8-3-15; 8:45 am]
BILLING CODE 4140-01-P
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